Consentimiento de Zelen y autonomía del paciente: una revisión narrativa

La obtención del consentimiento informado previo a la inclusión de los participantes en un ensayo clínico es un requisito ético-jurídico. En el diseño de Zelen la aleatorización es previa al consentimiento. En esta revisión se describen los estudios con aleatorización de Zelen y se analizan según lo establecido en España por la Ley 41/2002 Básica de Autonomía del Paciente, el RD 1090/2015 y la Ley 14/2007 de Investigación Biomédica. Se encontraron 78 estudios y se seleccionaron 23. El 61% eran “doble consentimiento”. En el 17,3% se justificaba el uso de este consentimiento porque incrementaba el reclutamiento de pacientes. El diseño de Zelen tiene varias limitaciones éticas. En los estudios revisados no aparecen argumentos claros para su utilización

Consentimiento de Zelen y autonomía del paciente: una revisión narrativa

Obtaining informed consent (CI) prior to the inclusion of participants in a clinical trial is an ethical-legal requirement. In the Zelen design randomization of subjects is prior to the application for consent to participate. In this review the studies with random of Zelen are described and analyzed according to the established in Spain by the Law 41/2002 Basic of Autonomy of the Patient, the RD 1090/2015 and the Law 14/2007 of Biomedical Investigation. 78 studies were found and 23 were selected. 61% was a "double assent". In 17,3% there was justifying itself the use of this consent because it was increasing the patients' recruitment. Zelen's design has several ethical limitations. In the studies analysed are no clear arguments for his utilization.La obtención del consentimiento informado previo a la inclusión de los participantes en un ensayo clínico es un requisito ético-jurídico. En el diseño de Zelen la aleatorización es previa al consentimiento. En esta revisión se describen los estudios con aleatorización de Zelen y se analizan según lo establecido en España por la Ley 41/2002 Básica de Autonomía del Paciente, el RD 1090/2015 y la Ley 14/2007 de Investigación Biomédica. Se encontraron 78 estudios y se seleccionaron 23. El 61% eran “doble consentimiento”. En el 17,3% se justificaba el uso de este consentimiento porque incrementaba el reclutamiento de pacientes. El diseño de Zelen tiene varias limitaciones éticas. En los estudios revisados no aparecen argumentos claros para su utilización

Equity and patient autonomy in the care strategies for patients with chronic disease of health services in Spain

Objetivo Analizar los modelos de atención a pacientes crónicos de los distintos servicios de salud en España y discutir las cuestiones éticas derivadas de la aplicación de algunos de sus componentes. Método Revisión narrativa de las estrategias y de los programas de atención a pacientes crónicos y el estudio de sus componentes, a partir de la búsqueda en las páginas web de las consejerías y departamentos de sanidad, utilizando los términos “Programas”, “Estrategias”, “Pacientes crónicos” y “Cronicidad”. Resultados Se encontraron 15 programas. En la mayoría se incluyen todos los componentes de los modelos de atención a pacientes crónicos, siendo el «apoyo a la toma de decisiones» el menos representado. Los principales conflictos en la autonomía de los pacientes surgen por el uso de bigdata para estratificar a la población y la telemonitorización. La estratificación de la población no considera los factores sociales que acompañan a la enfermedad. Conclusiones Las estrategias de atención a pacientes crónicos deberían considerar la autonomía y la intimidad de los pacientes en el uso de los datos clínicos y la telemonitorización. Para ser equitativas, deberían prestar una atención integrada e incorporar medidas para reducir las desigualdades debidas a los determinantes sociales que acompañan a la enfermedad.Objective To examine the chronic care models of the different Spanish health services and to discuss the ethical questions derived from implementing some of their components. Method Narrative review of care strategies and programmes for chronic patients in the different Autonomous Communities, searching in official health departments’ web pages, using the terms “Programmes”, “Strategies”, “Chronic patients”, and “Chronicity”. Results 15 programmes were found. Most of them include all components of the chronic care model, “decision-making support” being under-represented. The main conflicts in the autonomy of patients arise from the use of big data to stratify the population and from telemonitoring. The stratification of population does not consider the social factors that accompany the disease. Conclusions Chronic care strategies should consider the autonomy and privacy of patients in the use of clinical data and telemonitoring. In order to be equitable, they would have to provide an integrated health care system, incorporating measures to reduce the inequalities due to the social determinants that accompany the disease

Aplicabilidad de las herramientas de ayuda a la toma de decisiones compartidas en los servicios de urgencias: una revisión exploratoria

Fundamentos: Las herramientas de ayuda en la toma de decisiones (HATD) han sido muy utilizadas en las enfermedades crónicas, pero existen pocos estudios sobre su utilidad en los servicios de urgencias. El objetivo de este estudio fue analizar la utilización de las HATD en los servicios de urgencias. Métodos: Se realizó una revisión exploratoria. Se realizaron búsquedas de ensayos clínicos aleatorizados y controlados, revisiones sistemáticas y otros estudios secundarios donde se utilizaran las HATD para la asistencia a pacientes de cualquier edad en los servicios de urgencias, entre el 1 de enero de 2012 y el 1 de agosto de 2019. Dos revisores examinaron y seleccionaron los estudios. Se utilizaron las siguientes bases de datos: Pubmed, Embase, Web Of Science, Cuiden, Patient Decision Aids Research Group IPDAS Collaboration, Cochrane, Centres for Reviews and Dissemination, National Guideline Clearinghouse, Guidelines International Network. Resultados: Se incluyeron doce estudios, de calidad metodológica moderada-baja. Los pacientes del Grupo de Intervención (GI) tenían mayor conocimiento de la enfermedad (=3,6 frente a 3 preguntas correctas y =4,2 frente a 3,6) y más implicación en las decisiones (puntuación en OPTION: 26,6 contra 7 y 18,3 contra 7). El conflicto se redujo en el GI en las decisiones sobre pruebas de imagen en el traumatismo craneoencefálico (TCE) (=14,8 frente a 19,2). En el GI era menos frecuente el ingreso para realizar una prueba de esfuerzo en casos de dolor torácico de bajo riesgo (58% contra 77%; IC95%=6%-31%, y 37% contra 52%; p<0,001). Cuando se utilizaba una HATD en niños con diarrea o vómitos, en el 80% la decisión era seguir una rehidratación oral frente al 61% en el GC (p=0,001). Conclusiones: Las HATD en los servicios de urgencias mejoran el conocimiento de los pacientes sobre la enfermedad y la participación en los cuidados. Se necesitan más estudios para desarrollar HATD en los servicios de urgenciasBackground: Decision aid tools (DAT) have been widely used in chronic diseases, but there are few studies on their usefulness in emergency departments. The objective of this study was to analyse the applicability of DAT in emergency services. Methods: An exploratory review was conducted. Between January 1, 2012 and August 1, 2019, searches of randomised and controlled clinical trials, systematic reviews and other secondary studies where DAT are used to assist patients of any age in emergency services were conducted. The databases used were: Pubmed, Embase, Web Of Science, Cuiden, Patient Decision Aids Research Group IPDAS Collaboration, Cochrane, Centres for Reviews and Dissemination, National Guideline Clearinghouse, Guidelines International Network. Two reviewers analysed and selected the studies. Results: Twelve studies of moderate-low quality were included. The patients in the intervention group (IG) were more aware of their illness (=3.6 vs 3 correct answers and =4.2 vs 3.6), and more involved in the decisions (score in OPTION: 26.6 vs 7 and 18.3 vs 7). The conflict was reduced in the IG regarding those imaging tests in the TBI (traumatic brain injury; =14.8 vs 19.2). In the IG, admittance to perform effort tests was reduced in low-risk chest pain (58% vs 77%; CI95%=6%-31%, 37% vs 52%; p<0.001). When DAT were used in children with diarrhoea or vomiting, in 80% of the cases the decision was to use oral rehydration against 61% in the control group (CG, p=0.001). Conclusions: DAT in emergency services improve patient’s knowledge about the disease and their participation in care. More studies are needed to develop DAT in emergency service

Administration of Strategic Agreements in Public Hospitals: Considerations to Enhance the Quality and Sustainability of Mergers and Acquisitions

Merger processes between hospitals have high benefit potential for patients, staff and managers. This integration of health centres can improve the quality and safety in patient care. Additionally, cooperative processes enhance the sustainability of the health system, by increasing team spirit, giving innovative ideas and improving staff satisfaction. In this article, the critical factors for successful hospital mergers and acquisitions in the Public Health System were considered to develop a brief guide to help with the organisation of a merger process. Five sections were designed: Strategic administration and objectives, Staff management, New hospital complex structure, Processes and Results. This guide facilitates the communication between a variety of stakeholders, thus improving the engagement between all members of the new healthcare system. This could be particularly important for countries with large regional variance in the organisation of health care and resources

Administration of Strategic Agreements in Public Hospitals: Considerations to Enhance the Quality and Sustainability of Mergers and Acquisitions.

Merger processes between hospitals have high benefit potential for patients, staff and managers. This integration of health centres can improve the quality and safety in patient care. Additionally, cooperative processes enhance the sustainability of the health system, by increasing team spirit, giving innovative ideas and improving staff satisfaction. In this article, the critical factors for successful hospital mergers and acquisitions in the Public Health System were considered to develop a brief guide to help with the organisation of a merger process. Five sections were designed: Strategic administration and objectives, Staff management, New hospital complex structure, Processes and Results. This guide facilitates the communication between a variety of stakeholders, thus improving the engagement between all members of the new healthcare system. This could be particularly important for countries with large regional variance in the organisation of health care and resources

Administration of Strategic Agreements in Public Hospitals: Considerations to Enhance the Quality and Sustainability of Mergers and Acquisitions

Merger processes between hospitals have high benefit potential for patients, staff and managers. This integration of health centres can improve the quality and safety in patient care. Additionally, cooperative processes enhance the sustainability of the health system, by increasing team spirit, giving innovative ideas and improving staff satisfaction. In this article, the critical factors for successful hospital mergers and acquisitions in the Public Health System were considered to develop a brief guide to help with the organisation of a merger process. Five sections were designed: Strategic administration and objectives, Staff management, New hospital complex structure, Processes and Results. This guide facilitates the communication between a variety of stakeholders, thus improving the engagement between all members of the new healthcare system. This could be particularly important for countries with large regional variance in the organisation of health care and resources

Shared Decision-Making in Chronic Patients with Polypharmacy: An Interventional Study for Assessing Medication Appropriateness

Potentially inappropriate medications are associated with polypharmacy and polypathology. Some interventions such as pharmacotherapy reviews have been designed to reduce the prescribing of inappropriate medications. The objective of this study is to evaluate how e ective a decision-making support tool is for determining medication appropriateness in patients with one or more chronic diseases (hypertension, dyslipidaemia, and/or diabetes) and polypharmacy in the primary care setting. For this, a quasi-experimental study (randomised, controlled and multicentre) has been developed. The study compares an intervention group, which assesses medication appropriateness by applying a decision support tool, with a control group that follows the usual clinical practice. The intervention included a decision support tool in paper format, where participants were informed about polypharmacy, inappropriate medications, associated problems and available alternatives, as well as shared decision-making. This is an informative guide aimed at helping patients with decision-making by providing them with information about the secondary risks associated with inappropriate medications in their treatment, according to the Beers and START/STOPP criteria. The outcome measure was the proportion of medication appropriateness. The proportion of patients who confirmed medication appropriateness after six months of follow-up is greater in the intervention group (32.5%) than in the control group (27.9%) p = 0.008. The probability of medication appropriateness, which was calculated by the proportion of drugs withdrawn or replaced according to the STOPP/Beers criteria and those initiated according to the START criteria, was 2.8 times higher in the intervention group than in the control group (OR = 2.8; 95% CI 1.3–6.1) p = 0.008. In patients with good adherence to the treatment, the percentage of appropriateness was 62.1% in the shared decision-making group versus 37.9% in the control group (p = 0.005). The use of a decision-making support tool in patients with potentially inappropriate medications increases the percentage of medication appropriateness when compared to the usual clinical practice

Aplicabilidad de las herramientas de ayuda a la toma de decisiones compartidas en los servicios de urgencias: Una revisión exploratoria

Background: Decision aid tools (DAT) have been widely used in chronic diseases, but there are few studies on their usefulness in emergency departments. The objective of this study was to analyse the applicability of DAT in emergency services. Methods: An exploratory review was conducted. Between January 1, 2012 and August 1, 2019, searches of randomised and controlled clinical trials, systematic reviews and other secondary studies where DAT are used to assist patients of any age in emergency services were conducted. The databases used were: Pubmed, Embase, Web Of Science, Cuiden, Patient Decision Aids Research Group IPDAS Collaboration, Cochrane, Centres for Reviews and Dissemination, National Guideline Clearinghouse, Guidelines International Network. Two reviewers analysed and selected the studies. Results: Twelve studies of moderate-low quality were included. The patients in the intervention group (IG) were more aware of their illness (=3.6 vs 3 correct answers and =4.2 vs 3.6), and more involved in the decisions (score in OPTION: 26.6 vs 7 and 18.3 vs 7). The conflict was reduced in the IG regarding those imaging tests in the TBI (traumatic brain injury; =14.8 vs 19.2). In the IG, admittance to perform effort tests was reduced in low-risk chest pain (58% vs 77%; CI95%=6%-31%, 37% vs 52%; p<0.001). When DAT were used in children with diarrhoea or vomiting, in 80% of the cases the decision was to use oral rehydration against 61% in the control group (CG, p=0.001). Conclusions: DAT in emergency services improve patient’s knowledge about the disease and their participation in care. More studies are needed to develop DAT in emergency services.Fundamentos: Las herramientas de ayuda en la toma de decisiones (HATD) han sido muy utilizadas en las enfermedades crónicas, pero existen pocos estudios sobre su utilidad en los servicios de urgencias. El objetivo de este estudio fue analizar la utilización de las HATD en los servicios de urgencias. Métodos: Se realizó una revisión exploratoria. Se realizaron búsquedas de ensayos clínicos aleatorizados y controlados, revisiones sistemáticas y otros estudios secundarios donde se utilizaran las HATD para la asistencia a pacientes de cualquier edad en los servicios de urgencias, entre el 1 de enero de 2012 y el 1 de agosto de 2019. Dos revisores examinaron y seleccionaron los estudios. Se utilizaron las siguientes bases de datos: Pubmed, Embase, Web Of Science, Cuiden, Patient Decision Aids Research Group IPDAS Collaboration, Cochrane, Centres for Reviews and Dissemination, National Guideline Clearinghouse, Guidelines International Network. Resultados: Se incluyeron doce estudios, de calidad metodológica moderada-baja. Los pacientes del Grupo de Intervención (GI) tenían mayor conocimiento de la enfermedad (=3,6 frente a 3 preguntas correctas y =4,2 frente a 3,6) y más implicación en las decisiones (puntuación en OPTION: 26,6 contra 7 y 18,3 contra 7). El conflicto se redujo en el GI en las decisiones sobre pruebas de imagen en el traumatismo craneoencefálico (TCE) (=14,8 frente a 19,2). En el GI era menos frecuente el ingreso para realizar una prueba de esfuerzo en casos de dolor torácico de bajo riesgo (58% contra 77%; IC95%=6%-31%, y 37% contra 52%; p<0,001). Cuando se utilizaba una HATD en niños con diarrea o vómitos, en el 80% la decisión era seguir una rehidratación oral frente al 61% en el GC (p=0,001). Conclusiones: Las HATD en los servicios de urgencias mejoran el conocimiento de los pacientes sobre la enfermedad y la participación en los cuidados. Se necesitan más estudios para desarrollar HATD en los servicios de urgencias